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Written question asked by Christopher Chope (Conservative) on Wednesday, 9 March 2022, in the House of Commons. It was due for an answer on Monday, 14 March 2022 (named day). A holding answer was provided on Monday, 14 March 2022. A substantive answer was provided by Maggie Throup (Conservative) on Friday, 8 April 2022 on behalf of the Department of Health and Social Care.

Coronavirus: Ivermectin

Question

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 20 December to Question 88624 and the Answer of 28 February 2022 to Question 127264 on Coronavirus: Ivermectin2, what the decision making process was for the Ivermectin being (a) entered into the PRINCIPLE clinical trial and (b) made the subject of monitoring by the Therapeutics Taskforce; and for what reason it an application for licensing authorisation for the use of Ivermectin in the treatment of patients with covid-19 has to be made to the MHRA before it (i)conducts a safety, efficacy and quality review and (ii) consults the Commission on Human Medicines.

Answer

Ivermectin has been a controversial drug throughout the pandemic, with many clinicians prescribing globally with no clear evidence to demonstrate there is a benefit. Taking this into consideration and the need to generate evidence on ivermectin’s efficacy in the treatment for COVID-19, the PRINCIPLE trial investigators determined that its inclusion would provide further information. Many of the outcomes of clinical trials, such as RECOVERY, have shown that such treatments are ineffective, which informs our understanding.

Should the ivermectin arm of the PRINCIPLE trial produce positive outcomes, an application may be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA must assess the company’s compliance with Human Medicines Regulation requirements, including pre-clinical and clinical trials, manufacturing and pharmacovigilance legislation requirements and the manufacture of a product to determine its safety, quality, or efficacy, including input from the Commission on Human Medicines. A marketing authorisation application for the license of a medicinal product must be submitted by a legal entity registered with Companies House, as holding a marketing authorisation includes legal responsibilities.

Secondary information

Type
Written question
Reference
137222
Session
2021-22
Related items
Coronavirus: Ivermectin
Monday, 20 December 2021
Written questions
House of Commons
Subjects
Coronavirus Ivermectin
Link
View this Written question on www.parliament.uk